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Clinical Trials in the USA / NCT04268706
Active, not recruiting Phase 2

Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)

NCT04268706 · tracked via the Priya Life Science USA tracker
Sponsor
Tessa Therapeutics
Phase
Phase 2
Started
2021-02-01
Last updated
2023-04-05

Condition(s) studied

Hodgkin Lymphoma, AdultHodgkin Disease RecurrentHodgkin Disease RefractoryHodgkin Disease, Pediatric

Investigational drug(s) / intervention(s)

CD30.CAR-TFludarabine →Bendamustine →

CD30.CAR-T: Autologous CD30.CAR-T cells infused on Day 0 after the completion of lymphodepleting chemotherapy.

Fludarabine: Lymphodepletion chemotherapy (30 mg/m2/day) for 3 consecutive days

Bendamustine: Lymphodepletion chemotherapy (70 mg/m2/day) for 3 consecutive days

Study summary

This is a two-part, Phase 2, multicenter, open-label, single arm study to evaluate the safety and efficacy of autologous CD30.CAR-T in adult and pediatric subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma.

Eligibility

Sex
ALL
Min age
12 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Eligibility is determined prior to blood collection . Patients must satisfy the following criteria to be enrolled in the study: 1. Signed Informed Consent Form 2. Male or female patients who are 12 - 75 years of age 3. Histologically confirmed classical Hodgkin Lymphoma 4. Relapsed or refractory cHL that has failed at least 3 prior lines of therapy, including: * chemotherapy * BV and/or * PD-1 inhibitor Patients may have previously received an autologous and/or allogeneic stem cell transplant 5. CD30-positive tumor 6. At least 1 measurable lesion according to The Lugano Classification 7. Laboratory parameters: Hematological, renal and hepatic functions, and coagulation parameters * Hgb ≥ 8.0 g/dL * Total bilirubin ≤ 1.5 × ULN * AST and ALT ≤ 5 × the ULN * CrCl \> 45 mL/min * ANC \>1,000/µL * Platelets \>75,000/µL * PT or INR ≤ 1.5 × ULN; PTT or aPTT ≤ 1.5 × ULN 8. ECOG PS of 0 to 1 or equivalent \[either Karnofsky PS (for patients ≥ 16 year of age) or Lansky PS (for patients \< 16 years of age)\] 9. Anticipated life expectancy \> 12 weeks Exclusion Criteria: 1. Evidence of lymphomatous involvement of central nervous system (CNS) 2. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement 3. Active uncontrolled bleeding or a known bleeding diathesis 4. Inadequate pulmonary function defined as pulse oximetry \< 90% on room air 5. ECHO or MUGA with LVEF \< 45% 6. On-going treatment with immunosuppressive drugs or chronic systemic corticosteroids 7. Having received: * Anti-CD30 antibody-based therapy within 4 weeks prior to CD30.CAR-T infusion * Prior investigational CD30.CAR-T * CD30 bispecific agent within 8 weeks prior to CD30.CAR-T infusion * Autologous HSCT within 90 days or allogeneic HSCT within 180 days prior to CD30.CAR-T infusion 8. Currently receiving any investigational agents within 4 weeks prior to study enrollment; or received any tumor vaccines within 6 weeks prior to CD30.CAR-T infusion 9. Active acute or chronic graft versus host disease (GVHD) requiring immune suppression regardless of grade 10. Evidence of human immunodeficiency virus (HIV) infection 11. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) 12. Unresolved \> Grade 1 non-hematologic toxicity associated with any prior treatments 13. History of hypersensitivity reactions to murine protein-containing products or other product excipients 14. Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification 15. Active second malignancy or history of another malignancy within the last 3 years 16. Women who are pregnant or intending to become pregnant; women who are breastfeeding; persons with procreative potential not using and not willing to use 2 highly effective methods of contraception 17. Any other serious, life-threatening, or unstable preexisting medical conditions

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
City of Hope Comprehensive Cancer Center Duarte California
University of Chicago Medical Center Chicago Illinois
Children's Hospital of Philadelphia Philadelphia Pennsylvania
Sarah Cannon Research Institute Nashville Tennessee
MD Anderson Cancer Center Houston Texas

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04268706 on ClinicalTrials.gov ↗ ← All trials in the USA